Prediction of in-circuit coagulation using blood coagulation analyzer in CRRT

Region

Japan

Condition

Condition

critically ill patient

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

We will retrospectively investigate whether the blood coagulation analyzer "ROTEM" which can measure blood coagulation and fibrinolysis easily and quickly is a device capable of predicting in-circuit coagulation at CRRT.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Relationship between ROTEM parameter and in-circuit coagulation

Key secondary outcomes

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients in which ROTEM was measured at our hospital ICU and CRRT was performed

Key exclusion criteria

none

Target sample size

60

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name

Hiroomi Tatsumi

Organization

Sapporo Medical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code

Address

South 1 West 16, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Email

htatsumi@sapmed.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name

Hiroomi Tatsumi

Organization

Sapporo Medical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code

Address

South 1 West 16, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Homepage URL

http://sapmedicu.com/research.html

Email

htatsumi@sapmed.ac.jp

Sponsor

Institute

Department of Intensive Care Medicine, Sapporo Medical University School of Medicine

Institute

Department

Funding Source

Organization

Department of Intensive Care Medicine, Sapporo Medical University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Institutions

Other administrative information

Date of disclosure of the study information

2018

Year

04

Month

13

Day

Related information

URL releasing protocol

http://sapmedicu.com/research.html

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Of the ROTEM parameters, INTEM-CT, EXTEM-alfa angle, EXTEM-MCF were shown to be effective for predicting in-circuit coagulation.